Transcept Pharmaceuticals Announces Expected FDA Extension Of Regulatory Review Period For Intermezzo R
Transcept Pharmaceuticals, Inc. (Nasdaq: TSPT) announced that the U.S. Food and Drug Administration (FDA) has informed the company that it should expect to receive formal notice of a three month extension of the review period for the new drug application (NDA) for Intermezzo (R) (zolpidem tartrate sublingual tablet). The Intermezzo (R) NDA had been assigned a Prescription Drug User Fee Act (PDUFA) date of July 30, 2009. Under this revised timeline, Transcept now anticipates action from the FDA on the NDA on or before October 31, 2009. In the normal course of the Intermezzo (R) NDA review, the FDA previously requested additional information regarding middle of the night dosing instructions.
Women who have stable marriages or who have recently gained a partner reported better sleep than women who are unmarried or who have lost a partner, according to a new University of Pittsburgh study. To assess the effects of marital stability and relationship changes on sleep, the study's lead author, Wendy Troxel, Ph.D., assistant professor of psychiatry at Pitt's School of Medicine, examined data from 360 middle-aged Chinese, Caucasian and African-American women over eight years. The researchers found that women who were in a stable marriage had the highest quality sleep measured objectively and subjectively, and these results persisted even after controlling for other known risk factors for sleep, including age, ethnicity, socioeconomic status and depressive symptoms.
Neurim Pharmaceuticals Reports Long Term Efficacy And Safety For Circadin R For Insomnia In Elderly Patients
Neurim Pharmaceuticals presented the preliminary results of a large-scale Phase III study of Circadin(R) 2mg, prolonged release melatonin in insomnia, demonstrating long term efficacy and safety in elderly patients. The results were reported in the Late Breaking Abstracts session of SLEEP 2009, the 23rd Annual Meeting of the Associated Professional Sleep Societies, (APSS) held at Seattle, Washington. The SLEEP meeting attracts the largest audience of sleep specialists in world. Circadin(R) is a novel sleep medicine that has been approved by the European Commission pharmaceutical regulatory agency and the Israeli Ministry of Health for the short-term treatment of primary insomnia, characterized by poor quality of sleep in patients who are aged 55 and over.
Meditation may be an effective behavioral intervention in the treatment of insomnia, according to a research abstract presented at SLEEP 2009, the 23rd Annual Meeting of the Associated Professional Sleep Societies Results indicate that patients saw improvements in subjective sleep quality and sleep diary parameters while practicing meditation. Sleep latency, total sleep time, total wake time, wake after sleep onset, sleep efficiency, sleep quality and depression improved in patients who used meditation. According to principal investigator Ramadevi Gourineni, MD, director of the insomnia program at Northwestern Memorial Hospital in Evanston, Ill.
NUVIGIL Jet Lag Disorder Data Presented At The SLEEP 2009 23rd Annual Meeting Of The Associated Professional Sleep Societies
Cephalon, Inc. (Nasdaq: CEPH) presented results from a pivotal trial that showed NUVIGIL(R) (armodafinil) Tablets [C-IV] significantly improved wakefulness in people with excessive sleepiness associated with jet lag disorder. These phase three data were presented at the SLEEP 2009 23rd Annual Meeting of the Associated Professional Sleep Societies meeting in Seattle, Washington. NUVIGIL is currently indicated to improve wakefulness throughout the day for the millions of patients who struggle with excessive sleepiness associated with treated obstructive sleep apnea, shift work disorder and narcolepsy. "We know that jet lag disorder affects approximately two-thirds of international travelers and that eastbound flight across multiple time zones can be particularly troublesome.
If you are pregnant and your mate complains your frequent snoring is rattling the bedroom windows, you may have bigger problems than an annoyed, sleep-deprived partner. A new study from researchers at the Northwestern University Feinberg School of Medicine has found that women who reported frequent snoring during their pregnancy were more likely to develop gestational diabetes -- a condition than can cause health problems for the mother and baby. The study also found pregnancy increases the likelihood that a woman will snore. This is the first study to report a link between snoring and gestational diabetes. For the study, 189 healthy women completed a sleep survey at the time of enrollment (six to 20 weeks gestation) and in the third trimester.